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Telmisartan Plus Exercise to Improve Functioning in Peripheral Artery Disease (TELEX)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Northwestern University
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Mary McDermott, Northwestern University
ClinicalTrials.gov Identifier:
NCT02593110
First received: October 27, 2015
Last updated: September 21, 2016
Last verified: September 2016

October 27, 2015
September 21, 2016
October 2015
September 2020   (Final data collection date for primary outcome measure)
Six-minute walk performance [ Time Frame: Change from baseline to six-month follow-up ]

We will determine whether telmisartan therapy alone improves six-minute walk performance at six-month follow-up, compared to placebo.

We will determine whether telmisartan combined with supervised treadmill exercise achieves greater improvement in six-minute walk at six-month follow-up, compared to supervised exercise alone and compared to telmisartan alone, respectively.

Same as current
Complete list of historical versions of study NCT02593110 on ClinicalTrials.gov Archive Site
  • Maximal treadmill walking distance [ Time Frame: Change from baseline to six-month follow-up ]
  • Walking Impairment Questionnaire (WIQ) [ Time Frame: Change from baseline to six-month follow-up ]
  • SF-36 Physical Functioning score [ Time Frame: Change from baseline to six-month follow-up ]
Same as current
Calf muscle biopsy measures [ Time Frame: Change from baseline to six-month follow-up ]
Same as current
 
Telmisartan Plus Exercise to Improve Functioning in Peripheral Artery Disease
Telmisartan Plus Exercise to Improve Functioning in Peripheral Artery Disease
The TELEX trial will establish whether telmisartan alone improves walking performance in people with peripheral artery disease (PAD). The TELEX trial will also determine whether telmisartan plus supervised exercise improves walking performance more than either therapy alone. TELEX is a randomized controlled clinical trial (2 x 2 factorial design) of 240 participants with PAD randomized to one of four arms: Group A: telmisartan + supervised exercise therapy; Group B: telmisartan + a "no exercise" control group; Group C: placebo + supervised exercise therapy; and Group D: placebo + a "no exercise" control group.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Peripheral Artery Disease
  • Behavioral: Supervised Treadmill Exercise Therapy
    Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months.
    Other Name: Treadmill exercise
  • Drug: Telmisartan
    Participants randomized to the telmisartan arm of the study will take 40 mg of telmisartan daily. Participants will have their dose increased to up to 80 mg as tolerated.
    Other Name: Micardis
  • Other: "No exercise" control group
    Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months.
    Other Name: Attention control group
  • Drug: Placebo
  • Active Comparator: Telmisartan + Supervised Treadmill Exercise Therapy
    Participants in this group will receive both daily telmisartan and supervised treadmill exercise three days weekly for six months.
    Interventions:
    • Behavioral: Supervised Treadmill Exercise Therapy
    • Drug: Telmisartan
  • Active Comparator: Telmisartan + "No Exercise" Control Group
    Participants in this group will receive daily telmisartan and attend weekly educational lectures at the medical center for six months.
    Interventions:
    • Drug: Telmisartan
    • Other: "No exercise" control group
  • Active Comparator: Placebo + Supervised Treadmill Exercise Therapy
    Participants randomized to this group will receive daily placebo and supervised treadmill exercise three times weekly for six months.
    Interventions:
    • Behavioral: Supervised Treadmill Exercise Therapy
    • Drug: Placebo
  • Placebo Comparator: Placebo + "No Exercise" Control Group
    Participants randomized to this group will receive daily placebo and health education lectures weekly for six months.
    Interventions:
    • Other: "No exercise" control group
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
April 2021
September 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

All participants will have PAD. PAD will be defined as follows. First, an ABI <= 0.90 at the baseline study visit is an inclusion criterion for PAD. Second, potential participants who have an ABI > 0.90 but ≤ 1.00 and experience a 20% or higher drop in ABI after heel-rise exercise will be eligible. Third, potential participants with an ABI > 0.90 who have vascular lab evidence of PAD or angiographic evidence of PAD will be eligible. Finally, potential participants with a history of lower extremity revascularization who do not meet the criterion above and have an ABI > 0.90 with a 20% or higher drop in ABI after heel-rise exercise will be eligible.

Exclusion Criteria:

  1. Above or below knee amputation, critical limb ischemia, wheelchair confinement, inability to walk without a walker, or current foot ulcer.
  2. Walking is limited by a condition other than PAD.
  3. > Class II NYHA heart failure or angina, increase in angina, angina at rest, or abnormal baseline treadmill stress test. Potential participants may become eligible following an abnormal baseline treadmill stress test if they have evidence of an absence of coronary ischemia based on testing with their own physician.
  4. Currently taking an angiotensin receptor blocker or an ACE inhibitor or use of these medications in the past three months.
  5. Currently taking aliskiren (Tekturna).
  6. Blood pressure < 110/55 at baseline or potassium > 5.0 meq/L at baseline.
  7. Blood pressure < 100/50 after run-in or potassium >= 5.5 meq/L at the end of run-in.
  8. Severe hepatic impairment defined by two or more liver function enzyme values greater than 2.5 the upper limit of normal.
  9. Acute decline in renal function on telmisartan, defined as a 30% or greater decline in eGFR following the two-week run-in as compared to baseline.
  10. Allergy to ARBs.
  11. Failure to successfully complete the 2-week study run-in, defined as failing to attend the health education and treadmill exercise run-in sessions and/or failing to take the study medication daily for 10 or more days in the two-week period (i.e. one pill per day for > 10 days out of the 14 day run-in period).
  12. Surgery including lower extremity revascularization, coronary revascularization with stenting, or orthopedic surgery during the past 3 months or anticipated in the next 6 months or myocardial infarction or stroke in the past 3 months.
  13. Major medical illness including renal disease requiring dialysis, lung disease requiring oxygen, Parkinson's disease, a life-threatening illness with life expectancy less than six months, or cancer requiring treatment in the previous two years. [NOTE: potential participants may still qualify if they have had treatment for an early stage cancer in the past two years and the prognosis is excellent. Participants who only use oxygen at night may still qualify.]
  14. MMSE score < 23 or dementia.
  15. Currently walking regularly for exercise at a level similar to the study intervention.
  16. Participation in another clinical trial or cardiac rehabilitation or completion of a clinical trial or cardiac rehabilitation in the previous three months. [NOTE: after completing a stem cell or gene therapy intervention, participants will become eligible after the final study follow-up visit of the stem cell or gene therapy study so long as at least six months have passed since the final intervention administration. After completing an exercise intervention or a supplement or drug therapy (other than stem cell or gene therapy), participants will be eligible after the final study follow-up visit as long as at least three months have passed since the final intervention of the trial.]
  17. Non-English speaking, a visual impairment that limits walking ability, or a hearing impairment that interferes with study participation.
  18. Heart failure with an ejection fraction <40% at baseline.
  19. In addition to the above criteria, investigator discretion will be used to determine if the trial is unsafe or not a good fit for the potential participant.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Mary McDermott, MD 312-503-6419 mdm608@northwestern.edu
Contact: Kathryn Domanchuk, BS 312-503-6438 k-domanchuk@northwestern.edu
United States
 
 
NCT02593110
STU00200954
R01HL126117 ( US NIH Grant/Contract Award Number )
Yes
Not Provided
Undecided
Not Provided
Mary McDermott, Northwestern University
Northwestern University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Mary McDermott, MD Northwestern University
Northwestern University
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP